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Clinical Trials/NCT03208387
NCT03208387Active, not recruitingNot Applicable

Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Memorial Sloan Kettering Cancer Center4 sites in 1 country42 target enrollmentStarted: June 28, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
42
Locations
4
Primary Endpoint
Feasibilty which is the number of eligible survivors consented per month
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
6 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Children Treated for Posterior Fossa Tumors:
  • •As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease.
  • •For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy
  • •For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy).
  • •As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor.
  • •Subject is between the ages of 6 through 16 years at time of consent.
  • •As per medical record or parent report, subject is able to tolerate an MRI without sedation.
  • •Healthy Control Participants:
  • •No major medical illness, as determined by medical interview by study physician.
  • •As per parent report, subject is between the ages of 6 through 16 years at time of consent.
  • •As per parent report, subject is able to tolerate an MRI without sedation.

Exclusion Criteria

  • •All Participants:
  • •Full Scale IQ as documented to be below a standard score of <70 based upon the study IQ assessment completed after consent.
  • •As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year.
  • •MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.
  • •As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma).
  • •As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.

Outcomes

Primary Outcomes

Feasibilty which is the number of eligible survivors consented per month

Time Frame: 2 years

The study is a pilot study to collect information on feasibility broadly defined. The feasibility indicators are primarily descriptive variables, including a careful monitoring of accrual rate (how many eligible survivors consented per month).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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Understanding the Late Effects of... | Clinical Trial